The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Simvastatin

simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks

Group Type EXPERIMENTAL

simvastatin, placebo

Intervention Type DRUG

B1-6-12

B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks

Group Type PLACEBO_COMPARATOR

simvastatin, placebo

Intervention Type DRUG

Interventions

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simvastatin, placebo

Intervention Type DRUG

Other Intervention Names

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Bestatin B1-6-12

Eligibility Criteria

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Inclusion Criteria

* Stable COPD without an exacerbation within 3 months prior to study entry
* mild, moderate and severe COPD with or without treatments, regardless of COPD medications

Exclusion Criteria

* Concomitant other chronic lung diseases including with TB and malignancy
* HIV
* Being on immunosuppressive drugs and systemic corticosteroids
* Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
* Cognitive impairment
* Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No